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Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing (EXACT)

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ClinicalTrials.gov Identifier: NCT01592565
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Karolina Zareba, Ohio State University

Brief Summary:
This study is being done to demonstrate a powerful new method for detecting heart disease that combines the proven prognostic capability of exercise stress testing with the superior image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to exercise stress SPECT for detecting obstructive artery disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Diagnostic Cardiac Imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An In-state Multi-center Evaluation of Treadmill Exercise Stress Cardiac Magnetic Resonance
Study Start Date : August 2010
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Diagnostic Cardiac Imaging
    Cardiac Magnetic Resonance (CMR) offers superior image quality compared to echocardiography and nuclear imaging, and the ability to image both function and perfusion. Combining the superior image quality of CMR with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease. This project is expected to show that CMR is at least equivalent to nuclear stress imaging and could potentially replace it in many instances, eliminating the need for radioisotope administration and the associated exposure of patients to ionizing radiation.


Primary Outcome Measures :
  1. Exercise stress CMR has equivalent or superior diagnostic and prognostic value compared to exercise stress nuclear scintigraphy in patients suspected of CAD (coronary artery disease) [ Time Frame: baseline ]
    Exercise nuclear and CMR examinations including aggregate assessment of exercise parameters, ECG findings, myocardial perfusion, segmental left ventricular wall motion (CMR only), and viability will be independently reviewed offline by a consensus of two reviewers blinded to the results of the other imaging study, and each test will be classified as either negative/adequate stress, negative/inadequate stress, positive for ischemia, or fixed abnormality/no ischemia.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient referred for stress SPECT
  • known or suspected ischemic heart disease
  • ability to perform adequate treadmill stress

Exclusion Criteria:

  • any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia)
  • renal insufficiency (GFR < 40)
  • known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA (computed tomography angiography) in patients not referred for cath after 2 weeks)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592565


Locations
United States, Ohio
The Lindner Center at The Christ Hospital
Cinncinatti, Ohio, United States, 45219
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jennifer Dickerson, MD Ohio State University

Publications:
Responsible Party: Karolina Zareba, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT01592565     History of Changes
Obsolete Identifiers: NCT01504269
Other Study ID Numbers: 2007H0132 JD
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases